Efficacy of Pre-cooling and Sweet-tasting Solution on Pain Related to Local Anesthesia Injection in Children
Efficacy of Pre-cooling and Sweet-tasting Solution on Pain Related to Local Anesthesia Injection in Children: A Randomized Control Trial
The study aims to determine whether pre-cooling and sweet-tasting solutions, alone or combined with topical anesthesia, provide better pain control during dental local anesthesia in children.
It has two phases:
Phase 1: Identify the children's preferred sweet-tasting solution among xylitol, monk fruit, erythritol, and honey.
Phase 2: A randomized controlled trial comparing 7 groups involving pre-cooling, sweet solution, topical anesthesia, and their combinations.
The primary outcome is pain measured by VAS, while secondary outcomes include SEM behavioral response, heart rate, and oxygen saturation. The planned sample is 220 children.
Descripción general del estudio
Estado
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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El Sherouk
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Cairo, El Sherouk, Egipto
- Reclutamiento
- Faculty of Dentistry, British University in Egypt
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Contacto:
- Nada M Farouk, post graduate student
- Número de teléfono: +21020668262
- Correo electrónico: pg.nada92243007@bue.edu.eg
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Contacto:
- Ola A Abd El-geleel, Associate Professor
- Número de teléfono: +21006086830
- Correo electrónico: ola@dent.asu.edu.eg
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Sub-Investigador:
- Noha S Kabil, professor
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Investigador principal:
- Nada M Farouk, bachelors degree
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Sub-Investigador:
- Ola A Abd El-Geleel, associate professor
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Age group 7-11 years
- Patients requiring infiltration anesthesia to fulfill dental therapeutic needs
- Frankl behavior scale 3 and 4
Exclusion Criteria:
- Failure to provide assent or consent
- Allergy from local anesthetic solution
- Systemic diseases such as diabetes that could affect pain perception
- History of abscess or fistula at site of injection
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Precooling group
|
The intervention consists of pre-cooling and/or a sweet-tasting solution, used alone or in combination with topical local anesthesia, before administration of the dental local anesthetic injection. |
|
Experimental: Precooling + topical anaesthesia group
|
The intervention consists of pre-cooling and/or a sweet-tasting solution, used alone or in combination with topical local anesthesia, before administration of the dental local anesthetic injection. |
|
Experimental: Precooling + sweet tasting solution group
|
The intervention consists of pre-cooling and/or a sweet-tasting solution, used alone or in combination with topical local anesthesia, before administration of the dental local anesthetic injection. |
|
Experimental: Precooling + sweet tasting solution + topical anaesthesia
|
The intervention consists of pre-cooling and/or a sweet-tasting solution, used alone or in combination with topical local anesthesia, before administration of the dental local anesthetic injection. |
|
Experimental: Sweet tasting solution group
|
The intervention consists of pre-cooling and/or a sweet-tasting solution, used alone or in combination with topical local anesthesia, before administration of the dental local anesthetic injection. |
|
Experimental: Sweet tasting solution + topical anaesthesia group
|
The intervention consists of pre-cooling and/or a sweet-tasting solution, used alone or in combination with topical local anesthesia, before administration of the dental local anesthetic injection. |
|
Comparador activo: Topical anaesthesia group
|
The intervention consists of pre-cooling and/or a sweet-tasting solution, used alone or in combination with topical local anesthesia, before administration of the dental local anesthetic injection. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Visual Analog Scale (VAS)
Periodo de tiempo: Immediately after intervention
|
Pain Intensity assessed by visual analogue scale |
Immediately after intervention
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Phase 1 outcome
Periodo de tiempo: After intervention
|
The preferred sweet tasting solution based on number of patients |
After intervention
|
|
Heart Rate
Periodo de tiempo: Heart rate (beats per minute) measured immediately before needle insertion (baseline) and during needle injection and after needle injection
|
Heart rate (beats per minute) measured immediately before needle insertion (baseline) and the maximum heart rate recorded during needle injection and after needle injection |
Heart rate (beats per minute) measured immediately before needle insertion (baseline) and during needle injection and after needle injection
|
|
Sound, eye and motor scale (SEM) scale
Periodo de tiempo: During needle injection
|
Behavioral pain response during local anesthetic injection assessed using the Sound, Eye, and Motor (SEM) Scale. Sound, eye, and motor responses are each scored from 1 to 4, with 1 indicating comfort and 4 indicating a painful response. The three component scores are summed to obtain a total SEM score ranging from 3 to 12, with higher scores indicating greater behavioral response to pain. |
During needle injection
|
|
Oxygen saturation
Periodo de tiempo: Immediately before needle injection (baseline), during needle injection, and immediately after completion of injection. Recorded as percentage
|
Peripheral oxygen saturation (SpO₂) will be measured using a pulse oximeter and recorded as a percentage at three time points: immediately before local anesthetic needle injection (baseline), during needle injection, and immediately after completion of the injection. |
Immediately before needle injection (baseline), during needle injection, and immediately after completion of injection. Recorded as percentage
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 24-028
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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